The following data is part of a premarket notification filed by Kleengel, Llc with the FDA for Kleengel Dispenser.
| Device ID | K143177 |
| 510k Number | K143177 |
| Device Name: | KleenGel Dispenser |
| Classification | Dispenser, Liquid Medication |
| Applicant | KleenGel, LLC 136 NW 16th Street Boca Raton, FL 33432 |
| Contact | Suzanne Mair |
| Correspondent | Maria Griffin MDI CONSULTANTS, INC 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Product Code | KYX |
| CFR Regulation Number | 880.6430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-04 |
| Decision Date | 2015-09-14 |
| Summary: | summary |